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TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform (TASP-ESP)

Primary Purpose

Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use focused on measuring Tobacco, Alcohol, Prescription Drug, Illicit Substance Use, Screening, Spanish, Hispanic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 or older
  • A patient at the established clinic site
  • Spanish-language dominant (with ability to read Spanish)

Exclusion Criteria:

  • Unable to provide informed consent (e.g., due to acute impairment or psychosis)
  • Inability to comprehend or read Spanish
  • Inability to self-administer the iPad tool due to physical limitations
  • Previously enrolled in the study

Sites / Locations

  • Baylor Scott & White Research Institiute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Self-Administration followed by Interviewer-Administered

Interviewer-Administered followed by Self-Administration

Arm Description

Outcomes

Primary Outcome Measures

Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool)
To conduct a research-driven translation and adaptation of the TAPS Tool into a Spanish-language, self-administered mobile/tablet platform (TAPS-ESP), informed by cognitive interviews with 10 Spanish-speaking primary care patients.
Preliminary Examination of the translated Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
To conduct a preliminary examination of the validity of the TAPS-ESP with 100 Spanish-speaking primary care patients, compared to established Spanish-language reference standard measures
Feasibility and Acceptability of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
To determine the (a) feasibility and (b) acceptability of the TAPS-ESP (including patient perspectives and preferences regarding TAPS-ESP integration with electronic health records) among Spanish-speaking adult primary care patients, using a brief survey with the 100 participants in the validation study.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2019
Last Updated
August 19, 2019
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03879785
Brief Title
TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform
Acronym
TASP-ESP
Official Title
TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 1 STTR project will develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in a community health center. This will involve the adaptation of the TAPS into Spanish, its deployment on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.
Detailed Description
Linguistically Accurate Screening and Assessment is Critical for Quality Patient Care. Accurate screening, diagnosis and treatment are entirely dependent on a linguistically-accurate and culturally-relevant assessment, especially for sensitive topics such as substance use. Language accessibility is essential to quality healthcare, the lack of which is an independent predictor of poor control of chronic disease and a significant contributor to health disparities, lack of patient satisfaction with healthcare, and poor quality patient education and understanding of their disorder. Hispanics experience a disproportionate burden of disability associated with mental disorders because of these disparities. Primary care settings often are the gateway to identifying undiagnosed or untreated behavioral health disorders through effective screening. Thus, primary care settings can play a critical role in reducing behavioral health disparities by identifying individuals at risk of substance use problems. As the first steps in ensuring access to appropriate intervention or linkage to treatment services, screening and assessment are essential ingredients in quality care. It is widely believed that substance use problems are over represented in primary care settings, but providers lack the tools to effectively screen. Most of the patients seen in primary care are unlikely to seek treatment in the specialty behavioral health service system. Moreover, failure to identify unhealthy alcohol and other drug use can produce harmful medication interactions, resulting in significant clinical complications. The "Tobacco, Alcohol, Prescription medication, and illicit Substance use screening Tool (or TAPS Tool), is a two-stage screening and brief assessment tool that first screens the four broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substance use). In the second stage, the patient is assessed for more specific risks related to an expanded array of substances (tobacco, alcohol, cannabis, cocaine, methamphetamines, prescription stimulants, heroin, prescription opioids, sedatives, and other substances). The 4-item screener triggers brief assessment on these substance categories, and each substance yields a score of 0-3 (except alcohol, which is scored on a 0-4 range), which conveys to providers whether an intervention is indicated (a score of 1 suggests sub-diagnostic problem use; a score of 2 suggests substance use disorder). The TAPS Tool was validated against established diagnostic assessments in both interviewer-administered and self-administered iPad formats in a large, multi-site study (described in Preliminary Studies, below). However, only 11.7% of the original TAPS study sample reported Hispanic ethnicity, and the TAPS Tool currently exists only in an English language version. The Proposed Study: TAPS-Electronic Spanish Platform (TAPS-ESP). The current study proposes to develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in community health centers. This Phase 1 STTR project will involve: the adaptation of the TAPS into Spanish, its development on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use
Keywords
Tobacco, Alcohol, Prescription Drug, Illicit Substance Use, Screening, Spanish, Hispanic

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Administration followed by Interviewer-Administered
Arm Type
Active Comparator
Arm Title
Interviewer-Administered followed by Self-Administration
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Screening and validation of assessment tool translated into Spanish
Primary Outcome Measure Information:
Title
Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool)
Description
To conduct a research-driven translation and adaptation of the TAPS Tool into a Spanish-language, self-administered mobile/tablet platform (TAPS-ESP), informed by cognitive interviews with 10 Spanish-speaking primary care patients.
Time Frame
Estimated 4 Month
Title
Preliminary Examination of the translated Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
Description
To conduct a preliminary examination of the validity of the TAPS-ESP with 100 Spanish-speaking primary care patients, compared to established Spanish-language reference standard measures
Time Frame
Estimated 4 Month
Title
Feasibility and Acceptability of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
Description
To determine the (a) feasibility and (b) acceptability of the TAPS-ESP (including patient perspectives and preferences regarding TAPS-ESP integration with electronic health records) among Spanish-speaking adult primary care patients, using a brief survey with the 100 participants in the validation study.
Time Frame
Estimated 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 or older A patient at the established clinic site Spanish-language dominant (with ability to read Spanish) Exclusion Criteria: Unable to provide informed consent (e.g., due to acute impairment or psychosis) Inability to comprehend or read Spanish Inability to self-administer the iPad tool due to physical limitations Previously enrolled in the study
Facility Information:
Facility Name
Baylor Scott & White Research Institiute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32657958
Citation
Sanchez K, Gryczynski J, Carswell SB, Schwartz RP. Development and Feasibility of a Spanish Language Version of the Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use (TAPS) Tool. J Addict Med. 2021 Jan-Feb 01;15(1):61-67. doi: 10.1097/ADM.0000000000000699.
Results Reference
derived

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TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform

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